Capnographic Monitoring in Gastrointestinal Endoscopy for Elderly Patients (CapnoGI)

March 17, 2024 updated by: diansan su, RenJi Hospital

Capnographic Monitoring Decrease the Incidence of Hypoxia of the Elderly Patients Undergoing Gastrointestinal Endoscopy Procedure: a Randomized Multicenter Clinical Trial

Hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol and sufentanil, especially in elderly people. The aim of this randomized study was to determine whether intervention based on additional capnographic monitoring reduces the incidence of hypoxia in gastrointestinal endoscopes procedures for elderly patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhenzhou, Henan, China, 450003
        • Henan Provincial People's Hospital
    • Shandong
      • Qingdao, Shandong, China, 250012
        • Qilu Hospital of Shandong University
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • RenJi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 79 years (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 65 ≤ Age <80
  • patients undergoing gastrointestinal endoscopes
  • patients signed informed consent form
  • ASA classification I-II

Exclusion Criteria:

  • Coagulation disorders or a tendency of nose bleeding
  • An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months
  • Severe aortic stenosis or mitral stenosis
  • Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months
  • Acute myocardial infarction in the last 6 months
  • Acute arrhythmia (including any tachycardia - or bradycardia) with the fluid of hemodynamics instability
  • Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy)
  • Pre-existing bradycardia (heart rate < 50 / min), or hypoxia (SaO2< 90 % )
  • Need supplemental oxygen because of pre-existing diseases
  • Emergency procedure or surgery
  • Multiple trauma
  • Upper respiratory tract infection
  • Allergy to propofol or tape and adhesives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Capnographic monitoring group
In this group, in addition to the standard monitoring including observation, pulse oxygen saturation, non-invasive blood pressure, electrocardiogram in selected patients, the capnographic is also monitored. The capnographic data of the patients are available for additional noninvasive assessment of ventilation.
Device: Capnography monitoring
Standard monitoring and capnographic monitoring.
Device: Standard monitoring
Standard monitoring but no capnographic monitoring
Active Comparator: Standard monitoring group
In this group, standard monitoring including observation, pulse oxygen saturation, non-invasive blood pressure, electrocardiogram in selected patients. Capnographic data are not visible by closing the CO2 sampling line till the endoscopy end.
Device: Standard monitoring
Standard monitoring but no capnographic monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of hypoxia
Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
(75% ≤ SpO2 < 90% for <60 s)
Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of severe hypoxia
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
(SpO2 < 75% or 75% ≤ SpO2 < 90% for >/=60 s)
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of sub-clinical respiratory depression
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
(90% ≤ SpO2 < 95%)
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of capnography curve decreased by half or more than the baseline and even disappeared without hypoxia
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
capnography curve decreased by half or more than the baseline and even disappeared, SpO2 >90%
Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of other adverse events
Time Frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Patients will be followed for the duration of hospital stay, an expected average about 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

Qilu Hospital of Shandong University
Henan Provincial People's Hospital

Investigators

  • Principal Investigator: Diansan Su, Dr., Department of Anesthesiology Renji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

August 20, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RenjiH-20201201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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